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  • Assessing the clinical development & regulatory pathway for a Phase 3 gene therapy product


Our client, a PE-backed specialty pharma company growing rapidly through M&A, was assessing a number of late-stage development projects to license/acquire. The company was considering a Phase 3 stage gene therapy product that had suffered clinical and regulatory setbacks over recent years. We were asked to assess the clinical/regulatory development pathway to licensure and to assess the associated risks.


This was a project that Alacrita had assessed two years previously on behalf of an investor that had not proceeded with the deal, and we were able to deploy the same pharmaceutical physician to update their report based on progress since then. This proved efficient in terms of time and budget for the client. Despite the passage of time, we found the risk profile to be essentially the same as before, with clinical uncertainties at a level that cast significant doubt as to the clinical relevance of the effetiveness of the product. Our client decided not to pursue this transaction.

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